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SABR-COMET-10 trial that radiates up to 10 lesions

George71 profile image
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Because they were able to successfully treat a greater number of sites in these patients, the research team is now planning a follow-up study that will enroll patients with up to 10 metastatic lesions, called SABR-COMET-10.

"We don't know the upward limit of how many tumors can be treated with SABR," he said. "The concern is the amount of radiation exposure a patient can tolerate. We don't know yet what the safe boundaries are. We've been very conservative, as this is a new technology."

Nearly half (46 percent) of the patients treated with stereotactic radiation were still alive after five years, compared to 24 percent in the control group, said Dr. Palma—a result that he believes will encourage physicians to consider SABR as a treatment option.

"Ultimately, the question of whether an oncologist will offer this treatment as the standard of care for oligometastatic patients will be up to that oncologist," he said. "At the very least, physicians should be considering this as a treatment option for their patients."

"Stereotactic radiation therapy can increase how long these patients live and how long they live without their cancer coming back, and it doesn't seem to have a detrimental impact on their quality of life."

medicalxpress.com/news/2018...

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George71
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Tall_Allen profile image
Tall_Allen

That's been posted several times (including by me several months ago). You left out several important points:

•There were only 16 men with oligometastatic prostate cancer, and it is likely that in the 5 years of follow-up, NONE of them died of the disease, whether they were treated or not. So the results probably do not apply to prostate cancer, unless you mistakenly believe that all cancers are alike.

• 30% of the people in the study who received SBRT suffered serious side effects from their treatment that required medical intervention.

• 5% of the treated people died as a direct result of their treatment.

George71 profile image
George71

"NEARLY HALF (46 percent) of the patients treated with stereotactic radiation were still alive after five years, COMPARED TO 24 PERCENT in the control group, said Dr. Palma—a result that he believes will encourage physicians to consider SABR as a treatment option."

I'm going to stick with the doctors opinion over TA on this one.

Tall_Allen profile image
Tall_Allen in reply toGeorge71

Yes, but none of them from prostate cancer - you are drawing erroneous conclusions from the data.

George71 profile image
George71 in reply toTall_Allen

don't worry about it TA

Tall_Allen profile image
Tall_Allen in reply toGeorge71

I'm not worried G71, I'm just explaining your misunderstanding of the study.

TWTJr profile image
TWTJr

A note of no statistical importance: I, as a practicing radiologist, 6 years ago, and aware of the arbitrary limitation of "3 lesions or less" for SABR by most radio-oncologists at the time, provided some references of success treating more than 3 lesions to my radiation oncologist. He treated 6 lesions, scattered head to pelvis on me. My platelet count dropped somewhat, but otherwise treatment was uneventful, and I continued full time practice during this treatment. I consider the treatment highly successful, in that I have had no further progression or lesions. I remain on Dynamo trial of androgen suppression treatment. Now at 19 years from diagnosis.

j-o-h-n profile image
j-o-h-n in reply toTWTJr

19 years and another lucky guy... wishing you another 19 years at least.

One question, since I do not have a "pet" can I bring my rubber ducky when I get a pet

scan?

Good Luck, Good Health and Good Humor.

j-o-h-n Sunday 02/03/2019 6:06 PM EST

TWTJr profile image
TWTJr in reply toj-o-h-n

Ha! Good luck.

NPfisherman profile image
NPfisherman in reply toTWTJr

A wonderful story....thanks for all your posts... I hope my treatment is as successful as yours....19 years...dang....Keep fighting, brother...

TWTJr profile image
TWTJr in reply toNPfisherman

NP, sometimes when faced with potential lethal disease, with no scientifically proven, safe effective treatments, one must make difficult decisions. With potentially effective, if not curative, treatments being tested, with results incomplete, and your life is at stake, one may make a decision of risk vs reward that tilts more toward risk, as I have done several times in my course. In 2002, I chose to undergo high frequency ablation of a lesion of T2 at MDA (Dr Wallace, now deceased). This was a difficult procedure, very near the spinal cord, and quite painful. However, over the next 17 years, it has given me no clinical trouble, and I do not know if viable tumor at the site remains.

As I earlier stated, I underwent multilesion SABR about 6 years ago. No significant side effects, and all lesions stable at this time, while remaining on Lupron, and Dynamo Trial (for last 2.5 yrs). More recently, (2 years ago) I underwent thermal ablation of 3 rib and sternal lesions. All lesions gone, psa dropped by 50%. (0.6 to 0.3).

I have chosen to take risks, and at least to date succeeded. Whether by luck, good treatment or low grade tumor not progressing at this time no one knows. But I will go down fighting all the way, and take risks, perhaps some unknown, for the privilege of life, as well as any scientific use my course my reveal.

NPfisherman profile image
NPfisherman in reply toTWTJr

My theory exactly...I am not an MD like you, but I looked at the cards I was dealt...talked to the wife (She is the MD in our house, but does Physiatry) , and we chose stereotactic radiation...as she said, "Decrease the tumor burden and get whatever cancer we can find out of you..." It is a simple logic we endorsed...At this point, my PSA is undetectable (knock on wood) .... I do my RO f/u next month at UPMC--they are doing some of the trials for stereotactic radiation in oligometastatic disease. Hoping for the best...This is a beast and I believe in bludgeoning it...

All the best,

Fish

TWTJr profile image
TWTJr in reply toNPfisherman

May the force be with you!

NPfisherman profile image
NPfisherman in reply toTWTJr

and may it be with you...always... warriors to the end...

George71 profile image
George71

TWTJr

That is fantastic !!!

I am considering salvage pelvic lymph node -- those that drain the prostate only -- (they caution) and prostate bed radiation -- I am 3 years post surgery -- my current PSA is 0.6 they found microscopic PCa in 4 of 10 lymph nodes post surgery pathology. Some doctors have side for me to wait and do nothing until PSA is 5 to 10 or the cancer shows on CT scan -- I've had PSMA and F18 scans -- August 2018 both negative. What would you do if it were you? Do salvage or wait till it shows?

Bethpage profile image
Bethpage in reply toGeorge71

George, we are in the same boat. My husband's PSA after salvage a surgery in July of 2017, was 0.6. By November 2017, it rose to 1.0, then decreased to 0.9, 0.8, 0.7 X 2, back to 0.9, again down to 0.8, then again to 1.0, then 1.1 in early January and again early last week. In early December 2018, DCFPyL showed mildly increased uptake to *left* prostate bed. 68Ga RM2, done at the same time as DCFPyL, "seemed" to corroborate the findings. Last week, my husband visited Dr. Kwon, had Mayo's MRI, then the C-11 choline. Both Mayo's MRI and the C-11 choline showed mildly increased uptake to *right* prostate bed, along the line of the right seminal vesicle which was removed during salvage surgery in 2017. The struggle to make a decision based on these scans is indeed real.

Tall_Allen profile image
Tall_Allen in reply toBethpage

If he has never had salvage radiation of his prostate bed, what is "the struggle to make a decision" about?

George71 profile image
George71 in reply toBethpage

Hi Bethpage,

Yes that is much like what happened to me. Apparently they didn't think the cancer had left your husband's prostate to have done surgery? I was told that not many years ago if they saw any evidence of spread into lymph nodes or elsewhere they would simply sew you back up and put you on ADT.

I can only share what my experiences have been and would appreciate you keeping me updated on your husbands path as well-- it would be helpful.

I can tell you this much, I have seen EIGHT Drs. all specializing in PCa.

5 MOs and 4 ROs --- and that is not counting Dr. Kwon or Dr. Bob Liebowitz who reviewed my records and i conferred with via phone.

I contacted Dr. Kwon's office a year or so ago and they said I should wait till my PSA was 1.5 then come and get the c11 and go from there.

The one thing that is consistent among all the MO was -- don't start taking ADT until absolutely necessary except if I decided to do radiation and then only as short a time as possible. One RO said 4 to 6 months ADT (2months prior to starting radiation and stop after radiation is completed) he said maybe 40% chance no progression for 5 years. The other wants to do 12 months with Zytiga and another second level ADT. He said 20% chance of no biochemical failure or radiographic evidence of progression for 5 years. Both ROs want to radiate the lymph nodes that drain the prostate and the prostate bed. The Drs. PA said it is hard to come back and radiate nearby lymph nodes if prostate bed was radiated previously, due to possibility of radiation overlap. I have read on here that some of the men were radiated only in the prostate bed. They also told me that there is a very low probability of lymphedema colon or bladder issues but they are there and real -- he said 10%.

In my case it is highly likely there is micro mets in other lymph nodes, since they found it in 4 of 10 so I am leaning toward doing it rather than waiting.

For the record I was also told by surgeon that if I did nothing it would likely be 5 to 7 years before it would show on standard CT pet scan or bone scan or cause symptoms.

And when you consider the likelihood that several of the emerging therapies will come through big in the next 5 or 6 years it is really hard to know what to do.

My grandfather was born in 1885 he died of colon cancer in 1971 when he was 86. He was diagnosed with PCa around 1955 -- he did nothing -- he said everyone he knew who went to the hospital never came out -- he wouldn't go near one -- LOL.

My dad was radiated for PCa 35 years ago -- he is 99 will be 100 this year and still going. One of my uncles was radiated in the same year, he was 8 years older than my dad -- he died at 101. My other uncle was radiated for PCa apparently cured and died of dementia at 96. Back in those days the radiation dose was much less and fuzzy -- no ADT -- and according to my dad -- they were all cured or at least it never mattered. The radiation was less precise and that may have actually been better by getting surrounding micro mets that would have otherwise been left to grow and spread. Nowadays they don't seem to get it all and everyone is left with residual PCa coming back years later. IMO I think ADT speeds up a lot of the problems that had they not been rushed on to it many would possibly have lasted a lot longer. My urologist said PSA is just a number -- some have PSA of 5 and die and others have PSA in the thousands and live decades.

Bethpage profile image
Bethpage in reply toGeorge71

Yes, George, I would very much like to keep in touch and try to keep you updated. I hope that you will do the same. To that end, I am going to "follow" you and hope that you will do the same so that you can remind me. In my earlier reply to you, I offered a very abbreviated account of my husband's 4.5 year history with PCa . I intended to respond to you much earlier, but had emergencies today. I apologize. I also want to attempt to explain to Tall_Allen why we are "struggling" with a decision about treatment and get his feedback, but also would like to get other members' opinions as well. I realize that I (and my husband) may be "struggling" needlessly and am prepared to accept that and try to make a decision about treatment if a preponderance of you give me that feedback. I am going to make an independent post and hope that I can keep it short-winded enough that members will read and give me their experience and opinion because I do very much value every single one of you.

Tall_Allen profile image
Tall_Allen in reply toGeorge71

It is a mistake to assume that the cancer only lives in the few lymph nodes where it was detected. Lymph is a fluid and carries cancer cells. You should talk to your RO about treating ALL of your pelvic lymph nodes.

George71 profile image
George71 in reply toTall_Allen

they both said no -- only the ones that drain the prostate. MD Anderson and Houston Methodist

George71 profile image
George71

PS; So far only dietary change -- and supplements curcumin D3, C, Metformin and started Avadart about a year ago -- the Dr's are miffed -- PSA doubling time slowed to 22 months from 4 to 5 in first year post surgery.

TWTJr profile image
TWTJr

George, you have residual or recurrent disease, by way of PSA, uncertain location, possibly in the pelvis. I would go for the salvage pelvic and pelvic lymph node radiation, but only by a radiotherapist that does these treatments on a daily basis at a major cancer treatment center. I by nature am aggressive, knowing how difficult it is to isolate results of treatment when there are hundreds if not thousands of unrecognized variables that are unaccounted for in most clinical studies.

George71 profile image
George71 in reply toTWTJr

Thank you TWTjr,

I was considering M D Anderson or Methodist Houston (I live in Houston suburb).

I don't want to mess myself up any more than is needed. I think if we can all hang on for a few more years many of these new and promising treatments will come out.

Treatments have changed a lot in just the 3 years since my surgery. I would have done radiation in the beginning instead of surgery if the RO had not insisted I commit to 2 years ADT. At the time --prior to surgery -- no one thought it was anywhere but in my prostate -- they couldn't feel anything with digital exam) I said how about only 6 months ADT -- but they wouldn't consider it, -- so I went for surgery rather than radiation and 2 years of ADT. Now 3 years later -- one RO is recommending 4 to 6 months ADT with radiation -- the other RO is recommending 1 year plus Zytiga "throw the kitchen sink at it" was his words. And as I said, the MO said he thinks the best thing to do is do nothing til PSA is 5 or 10 or till it shows up somewhere if my anxiety level can stand it, then radiate and intermittent ADT.

TWTJr profile image
TWTJr in reply toGeorge71

George, I cannot recommend any specific rx, but my SABR was completed by Dr Brian Butler, chief radiotherapy at Houston Methodist. At this time I am a patient at MDA, but if further radiotherapy is required, I would prefer Methodist. Both institutions are state of art, but Methodist is a little less impersonal, and easier to communicate. Never hurts to get another opinion. Consults with Butler are not difficult to get. Consults with MDA radiotherapy are internal referrals, and you need to be a patient at Anderson to get one.

George71 profile image
George71 in reply toTWTJr

Thanks again,

I am leaning toward Dr. Butler I have met with him 3 weeks ago.

TWTJr profile image
TWTJr in reply toGeorge71

You are in good hands, George. As the saying goes, choose your poison!

George71 profile image
George71 in reply toTWTJr

Do you live in the Houston or did you have to travel

TWTJr profile image
TWTJr in reply toGeorge71

I live in central Houston. Retired radiologist, trained at MDA, Methodist, Hermann. You have at your convenience the best cancer therapy that is available.

George71 profile image
George71 in reply toTWTJr

I live in the Woodlands / Conroe / Montgomery area

NPfisherman profile image
NPfisherman

From a recent science daily--trial at UPMC--Dr Heron

sciencedaily.com/releases/2...

Issued January 31st--while only 7.5% of cancers were prostate--it looks good to me... The results were much better than TA listed--147 patients involved--see above--10% with SE

SABR-COMET-10 is coming...

I believe it will be another option in this war to extend life / find a cure...

All the best,

Fish

George71 profile image
George71 in reply toNPfisherman

I agree, I will have them zap anywhere they find it if it shows up. Dr. Kwon is a strong advocate for doing this and was years ahead of the curve. you can see his seminar videos on youtube.

NPfisherman profile image
NPfisherman in reply toGeorge71

Dr Kwon, Dr Karnes, and many others have a hit it hard and fast when opportunities open attitude...I was PT3A post surgery and 7 months later, they found a single lytic lesion on R clavicle--axumin scan....I was on Lupron and Zytiga within 2 weeks and within 2 months I received stereotactic radiation--3 sessions--my psa is undetectable--I am waiting to see RO in March... I had no SE and feel good about my decision. Fight the beast when you can...

All the best

Fish

George71 profile image
George71 in reply toNPfisherman

That is great news. I agree with trying to knocking it back everywhere you can find it as soon as it shows up.

Tall_Allen profile image
Tall_Allen in reply toNPfisherman

You are talking about a different study - not SABR-COMET, which is what George71 brought up. The study you are talking about was this one:

redjournal.org/article/S036...

As you can see (Table 1), there were even fewer men with prostate cancer in this study - only 11. More importantly, one can't draw ANY conclusions about efficacy because there was no control group to compare it to in this study. It is not surprising that with 40 months of follow-up, none of the men with prostate cancer had died. This doesn't tell you anything useful.

NPfisherman profile image
NPfisherman in reply toTall_Allen

I never said it was SABR-COMET--my post said it was a recent trial at UPMC--Dr Heron. I was VERY clear about that part...Indeed, a second trial...I was also aware that it was 11 men...I can do the math from my article....

They are expanding the trial at UPMC to 200...

Just to be clear, you are not advocating stereotactic radiation for men with oligometastatic disease in prostate cancer or any cancer for that matter...

Is that correct? Do you have a position? Either way...

You made no mention in the amount of SE/Deaths from this trial vs SABR-COMET..Thoughts??

Tall_Allen profile image
Tall_Allen in reply toNPfisherman

The only trials worth noticing are those that (1) include significant numbers of prostate cancer patients and (2) use a control group and (3) measure endpoints that are not dependent on PSA.

Yes, I have a position which I have consistently and frequently stated both here and in my blogs. My position is that until there is actual evidence of efficacy, it should only be done when it is entirely safe to do so.

I don't know why toxicity was so bad in the SABR-COMET trial. Perhaps the ROs were more careful about patient selection. I've heard from patients who shop around until they find ROs who will treat their mets. This is dangerous.

NPfisherman profile image
NPfisherman in reply toTall_Allen

Thank you for your reply... I am now clear that you do not recommend stereotactic radiation in oligometastatic disease for cancer patients...

Tall_Allen profile image
Tall_Allen in reply toNPfisherman

No, I did not at all say that. Your clarity is misplaced.

NPfisherman profile image
NPfisherman in reply toTall_Allen

well, one either endorses something, or they have no opinion, or they do not endorse it....for whatever reason... you stated:

Yes, I have a position which I have consistently and frequently stated both here and in my blogs. My position is that until there is actual evidence of efficacy, it should only be done when it is entirely safe to do so.

Thus, you do not endorse it...this is not a mystery....you state there is no proof of efficacy...perhaps, you mean only in prostate cancer patients...

NPfisherman profile image
NPfisherman in reply toTall_Allen

So....you have no position on stereotactic radiation in oligometastatic disease? I guess you can wait for the phase 3 trial...While that is a move of sorts, it deprives your followers of leadership input, and the potential for guidance at this early stage of development. Some may choose not to get tx based on your position.

Also, did you note the decreased number of SE in this trial. Are they just getting better at stereotactic radiation? Do you have thoughts on the matter?

Perhaps, you refuse to answer because you can not take a position on this matter... I certainly wouldn't want to believe it is a matter of rudeness...

All the best,

Fish

Tall_Allen profile image
Tall_Allen in reply toNPfisherman

I didn't refuse to answer - there is a 3 hour time difference and my inbox is flooded with emails from patients everyday who merit my attention. It may surprise you that responding to you is not my first priority.

NPfisherman profile image
NPfisherman in reply toTall_Allen

Not at all... as stated above.. it is clear to your followers that you do not endorse stereotactic radiation for oligometastatic disease in cancer patients...good enough..all clear..

Tall_Allen profile image
Tall_Allen in reply toNPfisherman

Once again - that is not at all what I wrote. You are fabricating fictions - re-read what I wrote.

NPfisherman profile image
NPfisherman in reply toTall_Allen

I did and responded above....let's not hop around like frogs--just address the above...thanks

Tall_Allen profile image
Tall_Allen in reply toNPfisherman

This is silly, and not worth any more of my time.

NPfisherman profile image
NPfisherman in reply toTall_Allen

It's ok not to endorse something because you feel there is a lack of proof of efficacy....on these cutting edge treatments, someone like yourself may choose not to endorse them... The problem for those of us that suffer from this disease is that there is a narrow window of opportunity--ie: oligometastatic state and we must make a choice..sometimes without a phase 3 trial...just like TWTJR did above...like I did...like George71 must do...I guess I will find out over time... This logic is not lost on you...

I am not questioning your logic or morals, sir....only what your stance was... I do get it...

All the best,

Fish

407ca profile image
407ca

George

I am very interested in your approach. I will be have SBRT to my oligomeastatic lesions beginning later today. 2 modes and one lesion on sternum. My primary radiation treatment has failed. After that I will have HIFU on prostate. I have never had ADT of any kind. Yes, I am well aware that it is not quite SOC but I am fine with that. This approach involves specialists from a couple cancer centers in the U S and one in Europe. Co-coordinating it all is a challenge but I feel well worth the effort. Who knows, we might learn something from it all.

All the best.

NPfisherman profile image
NPfisherman in reply to407ca

Good luck, brother....I had one met lytic lesion to my clavicle on axumin scan--got on Lupron and zytiga fairly quick and had stereotactic radiation--3 sessions to my lesion. I do my follow up in March. No pain or issues. I did feel a bit claustrophobic when they put the form over me and strapped me down... I believe in SOC, but believe to prolong life, one must look at a variety of methods--diet, exercise, meditation/ deep breathing, prayer, supplements, and of course, stereotactic radiation in battling the beast...

All the best,

Fish

Moespy profile image
Moespy in reply to407ca

407A,

Best wishes and outcome to you. I look forward to hearing your great results!

Jim

George71 profile image
George71

407ca and NPfisherman,

I agree with your logic --wishing you both good results.

tallguy2 profile image
tallguy2

OK, at a little bit of risk (but not much, given prior comments and their responses) I will weigh in with these data:

I specifically asked my RO about SBRT, and even handed him an article highlighting the potential benefits two weeks ago. His response: "I'll retire before this is forced on me by the insurance companies." SBRT, in some cases, takes treatment out of the hands of the doctors. 5 treatments at $1K a pop sounds a lot cheaper than my 26 treatments or other guys 45 treatments. Back to my RO: "There is a great risk of lymphodema or other side effects." Furthermore, as I mentioned in another post and was mentioned by Tall_Allen, this only targets the mets identified by, say, a PET/Axumin scan. There are likely other mets or microscopic areas not lit up by the PET. My RO had the foresight (and insurance company approval) to recommend IBRT (not just SBRT) and irradiate surrounding areas to the 3 identified mets, so that, perhaps, I will not be seeing him a third time around.

I am not saying that I am against SBRT. I am saying that a thoughtful discussion with your RO is required to determine what is best for your situation.

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